Mild Cognitive Impairment
Conditions
Keywords
cannabidiol, homotaurine, Mild Cognitive Impairment, Cognition, Mental Health
Brief summary
A Randomized Clinical Trial that will compare the effects of Cannabidiol and Homotaurine in cognition and mental health in patients with Mild Cognitive Impairment and APOE ε4 carriers. Ninety patients will be recruited and they will be randomly distributed in three groups. The first group will receive treatment with Cannabidiol 5%, the second group will receive treatment with Vivimind and the third group will not receive any treatment. The three groups will be compared by using an extensive neuropsychological examination and biomarkers' results from cerebrospinal fluid and blood
Interventions
DRUGCannabidiol Oil
Patients will use it with specific instructions and they will be monitored at least one time in a month
DRUGHomotaurine
Patients will use it with specific instructions and they will be monitored at least one time in a month
Sponsors
Greek Alzheimer's Association and Related Disorders
Aristotle University Of Thessaloniki
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Mild Cognitive Impairment * Carry APOE ε4 gene
Exclusion criteria
* Diagnosis of Dementia * Patients who receive medication for memory or depression * Patients who do not carry APOE ε4 gene
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Functional Rating Scale for Dementia | 12-24 months | Measurement of daily functionality |
| Changes in Trail Making Test A & B | 12-24 months | Screening tool to assess working memory and processing speed |
| Changes in Geriatric Depression Scale | 12-24 months | Screening tool to assess depressive symptoms |
| Changes in Rey Auditory Verbal Learning Test | 12-24 months | Screening tool to assess verbal memory and learning |
| Changes in Rey Osterrieth Complex Figure | 12-24 months | Screening tool to assess visuospatial memory |
| Changes in Mini Mental State Examination (MMSE) score | 12-24 months | — |
| Changes in Montreal Cognitive Assessment (MoCA) score | 12-24 months | Screening test to assess general cognitive function |
| Changes in Functional Cognitive Assessment (FUCAS) score | 12-24 months | Measurement of daily functionality |
| Changes in Letter & Category Verbal Fluency | 12-24 months | Measurement of verbal fluency, learning, long term memory and categorization skills |
| Changes in Clinical Dementia Rating Scale score | 12-24 months | Measurement of general cognitive function |
| Changes in ADAS-COG | 12-24 months | Measurement of general cognitive function |
| Changes in SAST | 12-24 months | Screening tool to assess anxiety |
| Changes in Beck Anxiety Inventory | 12-24 months | Screening tool to assess anxiety |
| Changes in Rivermead Behavioural Memory Test | 12-24 months | Screening tool to assess episodic memory and learning |
| Changes in STROOP Test | 12-24 months | Measurement of selective attention and cognitive flexibility |
| Changes in Symbol-Digit Test | 12-24 months | Measurement of processing speed, learning and working memory |
| Changes in BDNF | 12-24 months | Cerebrospinal Fluid Biomarker |
| Changes in MDA | 12-24 months | Cerebrospinal Fluid Biomarker |
| Changes in GFAP | 12-24 months | Cerebrospinal Fluid Biomarker |
| Changes in Tau-protein | 12-24 months | Cerebrospinal Fluid Biomarker |
Countries
Greece
Contacts
Primary ContactThanos Chatzikostopoulos, MSc
Outcome results
None listed